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FDA 510(k)

CARDIOVUE CFS-100

K-Number: K900893 · 1990-04-19

ApplicantBv Medical Equipment Co.
Decision Date1990-04-19
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CARDIOVUE CFS-100 is the device name listed in this FDA 510(k) record. The listed applicant is Bv Medical Equipment Co.. It received FDA 510(k) clearance on 1990-04-19 under 510(k) number K900893. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOVUE CFS-100?

CARDIOVUE CFS-100 is a medical device that received FDA 510(k) clearance on 1990-04-19. The listed applicant is Bv Medical Equipment Co.. The 510(k) number is K900893.

When did CARDIOVUE CFS-100 receive FDA 510(k) clearance?

CARDIOVUE CFS-100 received FDA 510(k) clearance on 1990-04-19, under 510(k) number K900893.

Who is the listed applicant for CARDIOVUE CFS-100?

The FDA 510(k) record lists Bv Medical Equipment Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARDIOVUE CFS-100?

The FDA product code for CARDIOVUE CFS-100 is JAA.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Bv Medical Equipment Co. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K842753OXYGEN CONCENTRATOR

Related Devices (Code: JAA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253103Nexus DRF Digital X-ray Imaging SystemVarex Imaging CorporationK251650Insight Enhanced™ DRF (EN-1002-01)Imaging Engineering, LLCK242488Soteria E-ViewOmega Medical Imaging, LLCK242948Adora DRFi (04550010)Nrt X-Ray A/SK233380TRIDENT Mobile Fluoroscopy SystemDornier Medtech AmericaK233945ProxiDiagnost N90 / Precision CRF (706110, 706400)Philips Medical Systems Dmc GmbH

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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